Combining acetaminophen and ibuprofen to treat heart issues in premature infants

Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants - The ACEDUCT Trial

This study is testing if giving premature infants both acetaminophen and ibuprofen together can help treat a heart problem called patent ductus arteriosus better than using just one of the medicines alone.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 310 (estimated)
• Ages: N/A to 27 Weeks
• Sex: All
• Sponsor: Mount Sinai Hospital, Canada (other)
• Locations: 9 sites (Newcastle, New South Wales and 8 other locations)
• Trial ID: NCT05340582 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of co-administering acetaminophen and ibuprofen to treat patent ductus arteriosus (PDA) in extremely premature infants born at less than 27 weeks gestation. PDA is a common cardiovascular complication in these infants, often leading to increased mortality and morbidity. The study aims to determine if this combination therapy can reduce treatment failure rates compared to using either medication alone. The trial will involve preterm infants diagnosed with PDA and will assess outcomes through echocardiography and clinical evaluations.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm infants born at less than 27 weeks gestation who have been diagnosed with PDA.

Not a fit: Patients with chromosomal anomalies or pre-existing renal or hepatic dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for extremely premature infants suffering from PDA.

How similar studies have performed: While combination therapies are emerging, this specific approach has not been widely tested, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

* Preterm infants born \<27+0 weeks gestational age
* Permission given by the attending clinician to approach and then consent obtained from parents
* Diagnosis of PDA ≥ 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt
* Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.

Exclusion Criteria:

* Chromosomal anomaly
* Pre-treatment renal dysfunction defined as urine output \< 1ml/kg/hour for the previous 24 hours or serum creatinine \> 100 micromol/L
* Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) \> 100 units/L94
* Platelet count \<50,000 per microliter
* Permission denied by the attending clinician to approach parents
* Parental consent not available
* Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment).

Where this trial is running

Newcastle, New South Wales and 8 other locations

• John Hunter Hospital — Newcastle, New South Wales, Australia (ACTIVE_NOT_RECRUITING)
• Royal North Shore Hospital — St Leonards, New South Wales, Australia (RECRUITING)
• Royal Alexandra Hospital — Edmonton, Ontario, Canada (RECRUITING)
• McMaster Children's Hospital — Hamilton, Ontario, Canada (RECRUITING)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
• Mount Sinai Hospital — Toronto, Ontario, Canada (RECRUITING)
• Centre Hospitalier de l'Université Laval — Québec, Quebec, Canada (NOT_YET_RECRUITING)
• Prince of Wales Hospital — Shatin, NT, Hong Kong (NOT_YET_RECRUITING)
• The Rotunda Hospital — Dublin, Ireland (ACTIVE_NOT_RECRUITING)

Study contacts

• Principal investigator: Amish Jain, MD PhD — MOUNT SINAI HOSPITAL
• Study coordinator: Laura Thomas, MSc

Conditions: Patent Ductus Arteriosus After Premature Birth, Preterm Neonates, Patent Ductus Arteriosus, Echocardiography, Acetaminophen, Ibuprofen